We are working with home based wireless blood pressure, glucometer, weight scales, PEF meters, Creatine and C-Reactive Protein meters to enable Pharma to define new approaches to trial design, conduct, safety monitoring, and overall quality improvements.
Chicago, IL (PRWEB) January 23, 2013
Carematix has supported the use of home telemonitoring in over 20 clinical trials in 14 countries over 115 sites and 1,000's of patients. The trials have been supported using various biometric sensors which patients use to transmit PRO data from home.
Carematix has been working with big pharma, and some NIH and VA funded clinical trials to support them with telehealth solutions. Almost all clinical trials have been multi-site and multi-country. Some trials have had as many as 24 sites over 5 countries. This raised interesting logistical challenges of shipping, training, deployment etc., especially when serving countries in Eastern Europe and Middle East like Romania, Bulgaria, Russia and Jordan. This has provided invaluable experience, which has led the development of a very robust workflow, policies and procedures. Carematix has also developed validated eCRF tools for both clinic and patient use. The web based and smart phone based solutions reduce cost for deployment, and provide near real time data for interim analysis.
"We are working with several new technologies that are intended to leverage the pervasive healthcare concept," said the head of operations and innovation, Novartis Pharmaceuticals Corp. Among these are wireless blood pressure, glucometer, and weight scales, home based electronic peak flow meters for asthma management, and several other novel devices like Creatine and C-Reactive Protein meters, which will enable Pharma to define new approaches to trial design, conduct, safety monitoring, and overall quality improvements. "The trial endpoints - both safety and efficacy are looked at carefully to determine if the design or conduct can be facilitated or improved by the use of the available pervasive healthcare devices”.
We have demonstrated PRO data is more reliable than patient diaries, which are prone to dry-labbing and transcription errors. The increased quality and quantity of data provides early identification of AE’s, improves patient safety and allows for development of secondary end points. “We are excited to have successfully facilitated multiple trials in multiple countries, and to continue to support more trials with our clinically validated data collection methodologies” says Dr. Sukhwant Khanuja, CEO Carematix Inc. “We believe this will lead to better and more robust clinical trial designs”.
About Carematix Inc
With offices in Chicago, USA and Delhi, India, Carematix is a leading provider of telehealth solutions for PRO in clinical trials. The proven end-to-end solutions have been clinically validated and audited by clients over the years.
Learn more at http://www.carematix.com
Contact: Sukhwant Khanuja
+1 (312) 627 9300